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Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception (CHIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01240811
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : July 22, 2013
Last Update Posted : December 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors).

Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.

The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.


Condition or disease Intervention/treatment
Genital Tract Mucosal Immunity Genital Tract Microflora Drug: IUD placement Drug: Levonorgestrel IUD Drug: Copper T380A IUD

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract
Study Start Date : November 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control-No IUD
Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Experimental: Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).
Drug: Levonorgestrel IUD
Other Name: Mirena IUD
Experimental: Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Drug: IUD placement
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).
Drug: Copper T380A IUD
Other Name: ParaGard IUD


Outcome Measures

Primary Outcome Measures :
  1. %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium [ Time Frame: 2 months ]
    Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety


Secondary Outcome Measures :
  1. Change in Vaginal Flora [ Time Frame: 2 Months ]
    Changes in vaginal flora as assessed by Nugent score The Nugent score is calculated by microscopically assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with bacterial vaginosis, 4-6 is consistent with intermediate vaginal flora, and 0-3 is normal vaginal flora.

  2. Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis [ Time Frame: 2 Months ]
    Changes in vaginal flora as assessed by qPCR quantitation of H2O2 producing Lactobacilli species and Gardnerella vaginalis. Quantitative PCR (qPCR) results are reported as log concentration of gene copies/swab specimen.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Non-pregnant, healthy females who are seeking an IUD for contraception
  2. Age 18-40 years, inclusive at the time of enrollment
  3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
  4. Willing and able to sign the informed consent and to comply with the study protocol

Inclusion criteria for healthy control subjects:

  1. Non-pregnant, healthy females
  2. Age 18-40 years, inclusive at the time of enrollment
  3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
  4. Willing and able to sign the informed consent and to comply with the study protocol
  5. Prior surgical sterilization or heterosexually abstinent

Exclusion Criteria:

  1. Use of any hormonal or intrauterine contraceptive method within the past two months
  2. Use of DMPA within the past 10 months
  3. Any of the following within the past two months:

    • Pregnancy or breastfeeding
    • Surgery/biopsy of the vulva, vagina, or cervix
    • History of STI
    • New sexual partner
  4. Evidence of vaginal/pelvic infection on screening

    • Abnormal wet mount (see description above)
    • Pelvic exam findings clinically consistent with infection
    • Positive screen for Gc, Ct, or HIV (will be excluded post randomization)
  5. Active HSV/ulcerative disease in the genital tract or perineum
  6. History of immunosuppression (diabetes, HIV, chronic steroid use)
  7. Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days
  8. Use of any systemic or vaginal steroid or antibiotic within the past 30 days
  9. Vaginal or anal intercourse within 1 week of sample collection
  10. Heterosexual vaginal intercourse since last menses without condom use
  11. History of hysterectomy
  12. History of malignancy in the uterus or cervix
  13. Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
  14. Allergy to copper and/or intolerance to levonorgestrel
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240811


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Sharon Achilles
Investigators
Principal Investigator: Sharon Achilles, MD, PhD University of Pittsburgh
More Information

Responsible Party: Sharon Achilles, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01240811     History of Changes
Other Study ID Numbers: PRO09100199
First Posted: November 15, 2010    Key Record Dates
Results First Posted: July 22, 2013
Last Update Posted: December 25, 2017
Last Verified: November 2017

Keywords provided by Sharon Achilles, University of Pittsburgh:
intrauterine device
IUD
levonorgestrel
copper
CD4
CCR5
microflora

Additional relevant MeSH terms:
Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Growth Substances